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The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. From navigating complex regulatory landscapes to ensuring the quality and safety of your products, every step of the process requires meticulous attention to detail. But have you ever stopped to think about the unsung heroes of generic drug development?
Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications. The article was published online in Statistics in Medicine.
Researchers report a discovery in cardiac regeneration that offers new hope for the treatment of ischemic heart failure. Published in npj Regenerative Medicine, the study reveals a novel approach to promoting cardiomyocyte proliferation. The researchers are from the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and collaborating institutions.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. Congratulations to the study teams from ARBOR-Telehealth, BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and the MOMs Chat & Care Study for reaching this important project milestone! ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities.
Studies reveal that people with Down syndrome (DS) have over a 90% lifetime risk of developing dementia caused by Alzheimer's disease (AD) as they age. Research from the University of Pittsburgh's Swanson School of Engineering aims could uncover why some people with DS develop dementia while others do not providing insight that could ultimately benefit the entire DS community.
Studies reveal that people with Down syndrome (DS) have over a 90% lifetime risk of developing dementia caused by Alzheimer's disease (AD) as they age. Research from the University of Pittsburgh's Swanson School of Engineering aims could uncover why some people with DS develop dementia while others do not providing insight that could ultimately benefit the entire DS community.
The Swiss pharma will base cardiometabolic drug research at the new Allston site. Elsewhere, AskBio advanced a gene therapy and Pfizer hired a scientist well versed in GLP-1 science.
Speakers Eduard Vasilevskis, MD, MPH Professor of Medicine Department of Medicine, Division of Hospital Medicine University of Wisconsin-Madison Michele C. Balas PhD, RN, CCRN-K, FCCM, FAAN Associate Dean of Research Dorothy Hodges Olson Distinguished Professor of Nursing University of Nebraska Medical Center College of Nursing Slides Keywords Intensive Care; ICU; Implementation; Evidence-Based Practices Key Points With recent increases in survivorship for Intensive Care U
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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Optum, the pharmacy benefit manager owned by UnitedHealth Group, placed Journavx on some of its commercial formularies in an interim decision while a formal review continues.
A team of researchers at the University Medical Center Schleswig-Holstein (UKSH), Kiel Campus, the Kiel University, and the Max Planck Institute for Molecular Genetics, Berlin, have developed an innovative method for real-time molecular genetic classification of brain tumors during surgery. This approach combines DNA methylation analysis with advanced machine learning technologies to provide detailed information about the tumor type during surgery.
Dr. Adam J. Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration.
Striking study results last year indicated a new type of medicine may improve on Merck’s dominant immunotherapy, spurring a wave of research practically overnight.
Craig Koch has been appointed as Velocitys new Executive Vice President, Europe, to spearhead the next phase of growth across the region. His appointment underscores the companys long-term commitment to Europe. Previously serving as EVP, Global Head of Sales, Craig has been with Velocity since 2019. He is now relocating to Europe to provide hands-on leadership as Velocity scales its integrated site network model across the continent.
This POV explores how decentralized healthcare models and data ownership are transforming patient loyalty, and highlights strategies to foster loyalty in this new landscape. Patient empowerment, patient-centric, choices, responsiveness, flexibility, competition and innovation are just a few of the positive attributes of decentralized healthcare delivery systems such as those in the United States.
A licensing deal with Denmark’s Gubra gives the immunology giant control of an experimental therapy that could compete with drugs from Novo Nordisk, Eli Lilly and Zealand.
Womens health remains one of the most overlooked and underrepresented areas in clinical research, often leading to gaps in treatment and understanding. Similar to obesity research, disorders relating to reproductive health include symptoms that are highly stigmatized and patients can be reluctant to seek treatment or join clinical trials. This is why Velocity set up a dedicated Womens Health Council to Accelerate Research Excellence (CARE Council).
Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Paul Evans sat down with Patricia Leuchten on the Leaders & Legends podcast, where they discussed the state of research sites and the broader industry. Listen now to hear Paul’s thoughts on: The evolution of clinical research sites and whats ahead for the industry. Challenges in patient recruitment and the role of site-based technology. His journey from growing up in Swansea, Wales, to leading the worlds largest research site organization.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
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Positive data from a pair of acute pain studies convinced the company that its drug, which works differently than existing medications, has a good shot at reaching market.
Introduction Pharmaceutical marketing has evolved. Traditional advertising methods alone no longer cut it in todays digital-first world. Social media advertising now plays a crucial role in reaching healthcare professionals (HCPs) and patients , allowing pharma brands to engage, educate, and build trust like never before. But heres the challenge: strict industry regulations make social media advertising tricky for pharma marketers.
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